Multiple-day efficacy of parecoxib sodium treatment in postoperative bunionectomy pain.
OBJECTIVE
To determine the analgesic efficacy of 1-day and multiple-day dosing regimens of parecoxib sodium (parecoxib) after bunionectomy in 2 randomized placebo-controlled studies.


METHODS
The first double-blind study assessed the efficacy of intravenous parecoxib 40 mg followed by an additional dose of parecoxib 20 mg, parecoxib 40 mg followed by placebo, or 2 placebo doses over 1 day. In the second study, all patients received parecoxib 40 mg and a second dose of 20 mg on day 1. On days 2 and 3, patients were randomized to parecoxib 20 mg once daily and placebo once daily, parecoxib 20 mg twice daily, or placebo twice daily. Rescue medication (hydrocodone 5 mg/acetaminophen 500 mg) was available throughout both studies.


RESULTS
In the single-day study, patients receiving parecoxib had significantly improved summed pain intensity difference through 24 hours, time-weighted sum of total pain relief through 24 hours, and Patient's Global Evaluation of Study Medication (PGESM) scores compared with those given placebo. In the multiday study, patients given parecoxib had significantly improved summed pain intensity through 24 hours and PGESM scores compared with patients receiving placebo. The incidence of adverse events was lower in the parecoxib groups than in the placebo group on days 2 and 3.


CONCLUSIONS
Parecoxib treatment, in conjunction with supplemental analgesia given as needed, provided effective pain relief over 1 to 3 days in the bunionectomy model of postoperative analgesia. Bunionectomy is a useful model for testing multiple-day analgesic therapy.
Apfelbaum
Jeffrey L
JL
Department of Anesthesia and Critical Care, University of Chicago Medical Center, Chicago, IL 60637, USA. jeffa@dacc.uchicago.edu
Desjardins
Paul J
PJ
Brown
Mark T
MT
Verburg
Kenneth M
KM
D000328:Adult; D000700:Analgesics / Q000008:administration & dosage* / Q000627:therapeutic use; D052246:Cyclooxygenase 2 Inhibitors / Q000008:administration & dosage* / Q000627:therapeutic use; D004334:Drug Administration Schedule; D005260:Female; D006215:Hallux Valgus / Q000601:surgery*; D006801:Humans; D007262:Infusions, Intravenous; D007555:Isoxazoles / Q000008:administration & dosage* / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement; D010149:Postoperative Pain / Q000188:drug therapy*; D016896:Treatment Outcome
D000700:Analgesics; D052246:Cyclooxygenase 2 Inhibitors; D007555:Isoxazoles; C409945:parecoxib